(59 days)
Hycem® Aplicap® is intended for final cementation of restorations composed of all classes of materials, including for cementation of crowns, bridges, inlays/onlays, pins and screws, and brackets and bands.
compomer luting cement, tradenamed Hycem® Aplicap®
This 510(k) summary for K963737 describes the Hycem® Aplicap® compomer luting cement. However, the provided text does not contain any information regarding clinical studies, acceptance criteria for device performance, or data related to AI/algorithm performance.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them, nor can I provide information on sample sizes, expert involvement, or ground truth, as none of this information is present in the provided document.
The document focuses on:
- Intended Use: Final cementation of restorations (crowns, bridges, inlays/onlays, pins, screws, brackets, bands).
- Substantial Equivalence Claim: To Dentsply Caulk's Advance™ Hybrid Ionomer Cement, based on similar intended use and composition.
- Performance Claim: Hycem® Aplicap® meets the requirements of relevant DIN and ISO standards for dental cement. This is a general statement about physical properties, not specific clinical performance metrics.
To answer your questions accurately, a document detailing performance studies (clinical or benchtop with specific acceptance criteria) would be required.
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NOV 1 5 1996
K963737 II. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
ESPE is submitting a 510(k) premarket notification for its compomer luting cement, tradenamed Hycem® Aplicap®. Hycem® Aplicap® is intended for final cementation of restorations composed of all classes of materials, including for cementation of crowns, bridges, inlays/onlays, pins and screws, and brackets and bands.
ESPE is claiming substantial equivalence to Dentsply Caulk's Advance™ Hybrid Ionomer Cement. These products have the same intended use and similar composition.
To support the substantial equivalence to predicate products, the composition and the physical and technical characteristics of Hycem® Aplicap® have been compared to those of Advance™ Hybrid Ionomer Cement. Hycem® Aplicap® meets the requirements of relevant DIN and ISO standards for dental cement.
ESPE's 510(k) has been submitted on September 17, 1996 by Dr. Barbara Wagner at Am Griesberg 2, D-82229 Seefeld, Germany (011-49-8152-700395).
§ 872.3275 Dental cement.
(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.